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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube Tracheostomy And Tube Cuff
510(k) Number K122932
Device Name SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT
Applicant
Fogless International AB
Storgatan 24
Vaggeryd,  SE 56732
Applicant Contact JASON WALTON
Correspondent
Fogless International AB
Storgatan 24
Vaggeryd,  SE 56732
Correspondent Contact JASON WALTON
Regulation Number868.5800
Classification Product Code
JOH  
Date Received09/24/2012
Decision Date 12/23/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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